BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UCSS SCREW SET

    MDR report key: 1945098 · Received January 3, 2011

    Report

    Report Number
    1030489-2011-00001
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE SCREWS THAT MAYBE BACKED OUT ARE CATALOG # G873H136, LOT #0091518W, EXPIRATION DATE 04/20/2018; CATALOG #G873H138, LOT #W06C0641, EXPIRATION DATE 03/08/2014. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 873-136 AND 873-138, 510K # K003928 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 0091518W IS 04/27/2010; THE MANUFACTURE DATE FOR LOT W06C0641 IS 05/05/2006. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IN ADDITION, ACCORDING TO THE REPORT, THIS INCIDENT IS NOT RELATED TO PRODUCT MALFUNCTION. WE ARE FILING AN MDR FOR NOTIFICATION PURPOSES. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CERVICAL PROCEDURE TO IMPLANT POSTERIOR FIXATION. THE POWERED INSTRUMENT COULD NOT FIT TO DRILL BIT THAT WAS USED TO HELP TO IMPLANT THE FIXATION SCREWS. THE DRILL BIT WAS NOT USED. ANOTHER INSTRUMENT WAS USED TO PREPARE THE HOLES TO IMPLANT THE SCREWS. IMMEDIATE POST OP IT WAS FOUND THAT THE ODONTOID SCREW WAS NOT IMPLANTED DEEP ENOUGH THEREFORE THE CONSTRUCT MAY NOT BE STABLE. THE REVISION SURGERY WAS PERFORMED 7 DAYS POST OP. ONE OF THE SCREWS WAS CONFIRMED BACKED OUT ABOUT 10MM FROM THE TREATED BONE. NO PATIENT COMPLICATIONS WERE REPORTED AFTER THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UCSS SCREW SET KWP WARSAW ORTHOPEDIC, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention